Illumina Acquires Regulatory Strategy Consulting Firm

By Bio-IT World Staff 

 

July 16, 2014 | Illumina today announced its acquisition of Myraqa, a consulting firm specializing in the regulatory strategy surrounding in vitro diagnostics, particularly companion diagnostics. 

 

Myraqa was founded in 1998, and is led by founder and CEO Mya Thomae. Thomae’s new title will be Vice President of Regulatory Affairs for Illumina. Her team will continue to report to her, and she will report to Illumina’s CMO. 

 

Myraqa offers application support, including PMAs, pre-submissions, IDEs, 510(k)s, de novo 510(k)s, and EU technical files. The acquisition will bolster Illumina’s in-house capabilities for clinical readiness (see, "MiSeqDx Foreshadows Expanded Universe of Clinical Sequencing") and help prepare for its next growth phase in regulated markets, the company said today in a press release. 

 

“Under Mya Thomae, Myraqa is recognized as the leader in regulatory and quality matters in molecular diagnostics,” said Rick Klausner, M.D., Chief Medical Officer of Illumina in the announcement. “With Myraqa, Illumina will continue to pave the way for the use of genomic technology, including next-generation sequencing, in regulated markets while also driving standards for use in the clinic. 

 

“Mya will lead Illumina’s regulatory strategy and execution, providing us with a world-class regulatory organization and is part of our commitment to making Illumina a pre-eminent clinical company. We expect Mya and her team to complete existing programs and to continue to work with selected third-parties on sequencing-based projects,” added Dr. Klausner.

 

San Diego Expansion 

 

In other Illumina news, the company announced an agreement with San Diego’s mayor, Kevin Faulconer, yesterday to enlarge its manufacturing operations within the city, adding about 300 manufacturing jobs. In return, the city of San Diego offered a rebate of $1.5 million in sales tax over ten years. 

 

The agreement is scheduled to go before the San Diego City Council next week for approval, which Faulconer’s office said is very likely, according to the San Diego Union Tribune.